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J Clin Epidemiol. 2011 Dec;64(12):1331-40. doi: 10.1016/j.jclinepi.2011.04.006. Epub 2011 Jul 20.

Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement.

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1
Sur la Croix 189, 1020 Renens, Switzerland.

Abstract

OBJECTIVE:

To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010.

STUDY DESIGN AND SETTING:

Four databases were searched for reports of CRTs in children (0-18 years). Characteristics of the studies were summarized and the quality of reporting assessed using consolidated standards of reporting trial-CRT (CONSORT-CRT).

RESULTS:

Of 1,949 identified references, 106 were included. The number of published CRTs in children increased since 2004. The greatest proportion of CRTs was undertaken in Europe (29%), whereas 40% was conducted in low- and middle-income countries. Most studies were of complex rather than simple interventions (83%); were preventive rather than treatment interventions (76%); and most frequently addressed infectious disease (21%), diet/physical activity interventions (19%), health-risk behaviors (15%), and undernutrition (13%). The majority used schools as units of randomization (72%) and enrolled 1,000-10,000 children per study (51%). Reporting was generally poor, with 34% of CRTs inadequately reporting on more than half of the CONSORT-CRT criteria. Although 85% of CRTs reported that they had ethics approval for the study, consent or assent was not obtained from children in most studies.

CONCLUSION:

Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation.

PMID:
21775103
DOI:
10.1016/j.jclinepi.2011.04.006
[Indexed for MEDLINE]

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